Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

NCT00112710 | Unknown Phase 3

• 3 other identifiers: CDR0000429610CRUK-BTOG2-LU3005EU-20510
• Study Type: interventional
• Target: 1,350
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Length of survival

Secondary Outcomes (6)

• Symptom control and quality of life as measured by the EORTC Quality of Life Questionnaire Core 30 Items and Lung Cancer supplement 13 together with EuroQol-5 domain questionnaire

• Treatment response as measured by RECIST criteria

• Dose intensity of chemotherapy

• Ratio of treatment courses given as in-patient versus out-patient

• Toxicity as measured by CTCAE v3.0

Interventions

carboplatin DRUG

cisplatin DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria: * Stage IIIB disease\* that is not suitable for radical radiotherapy * Stage IV disease\* NOTE: \*Radiographically verified * At least 1 measurable lesion by clinical examination or radiography * No mixed histologies of small cell lung cancer and NSCLC * No clinically apparent brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * At least 12 weeks Hematopoietic * WBC ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL Hepatic * AST \< 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Alkaline phosphatase \< 3 times ULN * Bilirubin \< 1.5 times ULN Renal * Creatinine clearance ≥ 60 mL/min (by Wright equation) OR ≥ 70 mL/min (by \^51Cr-EDTA clearance) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able and willing to participate in the quality of life assessment * No pre-existing neuropathy \> grade 2 * No other malignancy that would preclude study treatment or study comparisons * No evidence of severe or uncontrolled systemic disease, significant clinical disorder, or laboratory finding that would preclude study participation * No psychiatric disorder that would preclude study participation * No other condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy * No other concurrent cytotoxic chemotherapy Endocrine therapy * No concurrent hormonal therapy except contraceptives or replacement steroids Radiotherapy * No prior radiotherapy Surgery * Recovered from prior surgery * Prior surgical resection for NSCLC allowed Other * More than 12 weeks since prior investigational agents and recovered * No other concurrent specific antitumor therapy * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital Birmingham: lead

Study Sites (2)

Institute of Clinical Research - Birmingham

Birmingham, England, B15 2TT, United Kingdom

RECRUITING

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

RECRUITING

Related Publications (2)

• Gijtenbeek RG, de Jong K, Venmans BJ, van Vollenhoven FH, Ten Brinke A, Van der Wekken AJ, van Geffen WH. Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status. Cochrane Database Syst Rev. 2023 Jul 7;7(7):CD013382. doi: 10.1002/14651858.CD013382.pub2.

  PMID: 37419867 DERIVED

• Ferry D, Billingham L, Jarrett H, Dunlop D, Woll PJ, Nicolson M, Shah R, Thompson J, Spicer J, Muthukumar D, Skailes G, Leonard P, Chetiyawardana AD, Wells P, Lewanski C, Crosse B, Hill M, Gaunt P, O'Byrne K. Carboplatin versus two doses of cisplatin in combination with gemcitabine in the treatment of advanced non-small-cell lung cancer: Results from a British Thoracic Oncology Group randomised phase III trial. Eur J Cancer. 2017 Sep;83:302-312. doi: 10.1016/j.ejca.2017.05.037. Epub 2017 Aug 4.

  PMID: 28780466 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hugh Jarrett

  Institute of Clinical Research - Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: March 1, 2005
• Last Updated: August 26, 2013

Record last verified: 2007-05

Locations

GB (2)